The US Food and Drug Administration (FDA) has cleared Surrozen’s investigational new drug (IND) application for SZN-8141 to begin clinical trial for diabetic macular oedema.
The regulatory milestone satisfies the condition required for the second closing of the company’s March 2025 two-tranche private placement.
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Subject to standard closing conditions, the second closing is expected to occur on or around 20 October 2026 and generate approximately $95.1m in gross proceeds prior to deducting placement agent fees and other expenses.
Surrozen plans to use the funding to advance its therapeutic candidates, SZN-8141 and SZN-8143, as well as for general operational activities.
Within 30 calendar days of the second closing, the company is required to file a Form S-3 registration statement with the US Securities and Exchange Commission to register the resale of related shares and warrant-linked stock.
Surrozen CEO Craig Parker said: “FDA clearance of the SZN-8141 IND marks an important milestone for Surrozen as we advance our Wnt-based ophthalmology pipeline into clinical development.
“We look forward to initiating the DUET study and evaluating SZN-8141 in patients with diabetic macular oedema.”
Surrozen intends to dose the first patient in its DUET Phase Ib/IIa clinical trial during the fourth quarter of 2026, with preliminary findings expected in the second half of 2027.
Designed as an intravitreal injection, SZN-8141 is a bifunctional antibody combining Frizzled 4 (FZD4)-mediated Wnt agonism and vascular endothelial growth factor (VEGF) antagonism.
The first stage of the trial will assess single ascending doses for safety, tolerability, and retinal function over three months in treatment-naïve and previously treated patients.
The subsequent randomised Phase IIa portion will compare two dose strengths against Vabysmo (faricimab-svoa) in roughly 60 treatment-naïve patients over a four-month follow-up period.
Surrozen also plans to evaluate SZN-8141 for neovascular age-related macular degeneration and other retinal vascular disorders.
Additionally, the company is developing SZN-8143, a multi-target candidate combining FZD4 agonism, interleukin-6 antagonism, and VEGF antagonism for DME, neovascular age-related macular degeneration, and uveitic macular oedema.
